NDAINTRAVENOUSPOWDERPriority Review
Approved
May 2014
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
16
Data completeness
7/8 — Comprehensive
Priority Review
DALVANCE (dalbavancin) by AbbVie is [see microbiology ( )] . Approved for acute bacterial skin and skin structure infection, cellulitis, wound infection and 2 more indications. First approved in 2014.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DALVANCE (dalbavancin) is an intravenous lipoglycopeptide antibiotic approved by FDA in May 2014 for acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive organisms including methicillin-resistant Staphylococcus aureus (MRSA), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae, and S. anginosus group. The drug functions as a cell wall synthesis inhibitor with an extended half-life enabling less frequent dosing compared to traditional vancomycin. DALVANCE occupies a niche position in the IV Gram-positive antibiotic market, competing with established agents like daptomycin and ceftaroline while offering clinical convenience through reduced infusion frequency.
$0.0BPart D
2.1 years to LOEMechanism of Action
[see Microbiology ( )] .
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.